Industry
Freyr is a trusted partner in achieving excellence through strategic Device Life Cycle Management (DLCM). As the landscape of medical devices evolves, ensuring Regulatory compliance and efficient management across the entire life cycle becomes paramount. Our services, inspired by industry best practices and guided by expertise, aim to empower your journey at every stage.
Understanding Device Life Cycle Management:
The medical device life cycle management can be divided into six (06) distinct parts, with unique Regulatory requirements that apply in each phase.
Concept
In the concept phase, a medical device is merely an idea aimed at solving a medical issue more efficiently or cost-effectively. Here, developers define the device, explore funding and potential market routes, and establish initial device requirements.
Planning
In the planning phase of medical devices, user needs are gathered and transformed into technical requirements for the final device. Engineers may create prototypes, develop a Regulatory strategy, assess device risks, compile a design file, and expand the project plan for market introduction.
Design
After setting the requirements, the medical device moves into the design stage. Engineers refine the device design, gather user feedback, conduct verification and validation, and initiate technical documentation. This phase may involve brand development alongside the commencement of a manufacturing process for mass production.
Validation
In the validation stage of the device life cycle, medical device firms perform clinical validation tasks to ensure the device's safety and efficacy. The device meets all the Labeling requirements and Regulatory submissions are prepared for marketing in the targeted regions.
Launch
After obtaining marketing approval, the medical device transitions to the launch phase of its life cycle. It is introduced to healthcare providers, hospitals, and clinics, with the manufacturer offering training and support for the device's effective utilization.
Post-market
After entering the market, a medical device transitions to the post-market phase of its life cycle. Surveillance activities ensure reporting of adverse events, potential clinical studies, addressing complaints, making improvements, and potentially expanding to new markets if the device is successful.
Key Aspects of Device Life Cycle Management Consultancy:
- Regulatory Strategy Development: Crafting a robust Regulatory strategy aligned with global standards to ensure compliance at every stage of the device life cycle.
- Product Development Support: Providing guidance on Regulatory planning during product development, anticipating and proactively addressing potential hurdles.
- Market Entry Assistance: Facilitating seamless market entry by navigating complex Regulatory approvals, including submissions to the FDA,EMA, CDSCO,TGA, and other global Regulatory bodies.
- Post-market Surveillance (PMS): Ensuring ongoing compliance through effective PMS strategies, supporting continuous improvement, and adherence to evolving regulations.
- Lifecycle Maintenance: Advising on updates, modifications, and re-certifications to ensure your devices stay compliant and competitive throughout their life cycle.
Why Choose Freyr for Device Life Cycle Management?
Freyr specializes in device life cycle management, a comprehensive approach that encompasses the entire life span of a medical device, from conceptualization to obsolescence.
- Expertise Inspired by Best Practices: Our team draws on industry best practices to provide strategic insights and guidance tailored to meet your unique device life cycle management needs.
- Proven Track Record: Freyr has a successful history of helping clients navigate the challenges of device life cycle management, ensuring compliance and optimal performance.
